Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP

Completed

• Conditions: Multivessel Coronary Artery Disease
• Interventions: Procedure: comparison of PCI vs. CABG in multivessel disease

• Registration Number: NCT01199419
• Lead Sponsor: Medical University of Vienna

Brief Summary

The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• two or three-vessel disease requiring percutaneous or surgical multivessel intervention with the aim of complete revascularization
• age > 18 years
• clinical symptoms (stable or unstable angina) or signs of myocardial ischemia
• ≥ 50% diameter stenosis of each lesion

Exclusion Criteria

• acute myocardial infarction (< 48 h);
• contraindications to clopidogrel, aspirin, heparin and taxol;
• pregnancy or lack of protection against pregnancy or breast-feeding during the study;
• hemorrhagic diathesis and platelet count <100.000/ml3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CABG	comparison of PCI vs. CABG in multivessel disease	-
PCI	comparison of PCI vs. CABG in multivessel disease	-

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.	10 years

Secondary Outcome Measures

Name	Time	Method
Occurrence of cardiac death	10 years
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke	10 years
Rate of target vessel revascularization	10 years
Occurrence of non-fatal acute myocardial infarction	10 years
Calculation of the total costs	10 years

Trial Locations

Locations (1)

Medical University of Vienna, Dept. of Cardiology; 🇦🇹 Vienna, Austria